Otezla Resulted in Clinically and Statistically Significant Improvements in Measures of Genital Psoriasis at Week 16 Compared With Placebo
Safety and Tolerability Data Were Consistent With Known Safety Profile of Otezla
THOUSAND OAKS, CA, USA I December 1, 2021 I Amgen (NASDAQ: AMGN) today announced positive top-line results from the DISCREET trial, a Phase 3, multicenter, randomized, placebo-controlled, double-blind study to assess the efficacy of Otezla® (apremilast) in adults with moderate to severe genital psoriasis and moderate to severe plaque psoriasis. The study showed that oral Otezla 30 mg twice daily achieved a clinically meaningful and statistically significant improvement, compared with placebo, in the primary endpoint of the modified static Physician’s Global Assessment of Genitalia (sPGA-G) response (defined as an sPGA-G score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline) at week 16.
In addition, all secondary endpoints were also met with meaningful and significant improvements in Genital Psoriasis Itch Numerical Rating Scale (GPI-NRS) response (defined as at least a 4-point reduction from baseline in GPI-NRS item score within the Genital Psoriasis Symptoms for subjects with a baseline score of ≥ 4); affected body surface area (BSA) change from baseline; Dermatology Life Quality Index (DLQI) change from baseline; and static Physician’s Global Assessment (sPGA) response (defined as sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline) at week 16 with Otezla versus placebo.
“Genital psoriasis is associated with a high level of stigmatization and burden of disease and can be experienced in up to 63% of psoriasis patients over the course of their disease. Despite the use of topical therapies for the treatment of genital psoriasis, many patients still have challenges managing their disease, prompting experts to recommend the use of systemic therapies,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “The results from the DISCREET trial further add to the growing body of evidence on the safety and effectiveness of Otezla in moderate to severe plaque psoriasis, including manifestations with high unmet medical needs, such as genital psoriasis.”
The type and rate of adverse events observed in this trial were consistent with the known safety profile of Otezla. The most commonly reported adverse events that occurred in at least 5% of patients in either treatment group were diarrhea, headache, nausea and nasopharyngitis.
Patients completing the double-blind phase of the trial continued or switched to Otezla during the extension phase of the study and will be treated through week 32. The study is ongoing and is planned to complete in the first half of 2022.
Detailed results from the 16-week double-blind phase of the study will be submitted for presentation at an upcoming medical conference.
In the U.S., Otezla is approved for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, adult patients with active psoriatic arthritis and for adult patients with oral ulcers associated with Behçet’s Disease. Since its initial FDA approval in 2014, Otezla has been prescribed to more than 650,000 patients worldwide with moderate-to-severe plaque psoriasis, active psoriatic arthritis or Behçet’s Disease.1
About DISCREET (PSOR-025)
DISCREET (PSOR-025) is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study evaluating the efficacy and safety of Otezla in patients with moderate to severe genital psoriasis (defined as modified sPGA-G score ≥ 3). Patients also had moderate to severe plaque psoriasis (sPGA score ≥ 3) with BSA involvement ≥ 1% in a non-genital area and had an inadequate response or intolerance to topical therapy for psoriasis affecting the genital area. The study randomized 289 patients 1:1 to receive Otezla 30 mg twice daily or placebo for the first 16 weeks. Following the 16-week placebo-controlled, double-blind phase of the trial, patients continued or switched to Otezla during the extension phase of the study and will be treated through week 32.
The primary endpoint was the proportion of patients who achieve modified sPGA-G response at week 16 (defined as modified sPGA-G score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline at Week 16).
About Psoriasis
Psoriasis is a serious, chronic inflammatory disease that causes raised, red, scaly patches to appear on the skin, typically affecting the outside of the elbows, knees or scalp, though it can appear on any location.2 Approximately 125 million people worldwide have psoriasis, including around 14 million people in Europe and more than 7.5 million people in the United States3,4 About 80% of those patients have plaque psoriasis, the most common type of the disease.5 Up to 63% of patients with psoriasis are affected in the genital area at any time during the course of the disease.6
About Otezla® (apremilast)
Otezla® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which Otezla exerts its therapeutic action in patients is not well defined.
Otezla® (apremilast) U.S. INDICATIONS
Otezla® (apremilast) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.
Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.
Please click here for Otezla® Full Prescribing Information.
Amgen Inflammation
Amgen brings therapies to millions of people with inflammatory diseases, with a focus on serving unmet patient needs. For those with debilitating moderate-to-severe rheumatoid arthritis, psoriatic arthritis, moderate-to-severe plaque psoriasis, ankylosing spondylitis, asthma, and other chronic conditions, the suffering and needs are severe. Complex diseases of inflammation have defied simple solutions, and the breadth of inflammatory disease and the burden patients bear is not well understood.
For more than two decades, Amgen has been committed to advancing the science and the understanding around inflammation to address the unmet patient needs that exist and expanding our portfolio. We lead with science through discovery research that is disease-agnostic and biology-first, modality-second. In doing so, we have introduced and evolved novel therapies that have changed the lives of patients.
Our commitment to patients is reflected not only in where we have succeeded, but in where we have failed and opened new doors. Throughout, we have remained dedicated to the principle of leading with science, pursuing where pathways and promising discoveries in inflammation take us, and not relenting until innovative solutions for patients are found. It’s a commitment that extends beyond introducing novel therapies.
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be the world’s largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2021, Amgen was named one of the 25 World’s Best Workplaces™ by Fortune and Great Place to Work™ and one of the 100 most sustainable companies in the world by Barron’s.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
Data on File at Amgen Inc.
2National Psoriasis Foundation. About Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis. Accessed January 24, 2020.
3National Psoriasis Foundation. Statistics. Available at: https://www.psoriasis.org/content/statistics. Accessed January 24, 2020.
4Ortonne JP, Prinz JC. Alefacept: a novel and selective biologic agent for the treatment of chronic plaque psoriasis. Eur J Dermatol. 2004;14(1):41–45.
5National Psoriasis Foundation. Plaque Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis/types/plaque. Accessed January 24, 2020.
6 Kim A. P. Meeuwis, Alison Potts Bleakman, Peter C. M. van de Kerkhof, Yves Dutronc, Carsten Henneges, Lori J. Kornberg & Alan Menter: Prevalence of genital psoriasis in patients with psoriasis. Journal of Dermatological Treatment, 29:8, 754-760, DOI: 10.1080/09546634.2018.1453125
SOURCE: Amgen
